Drug recalls

CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

Official ID D-0657-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Official ID D-0656-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

prednisoLONE Acetate Ophthalmic Suspension recall — Lupin Pharmaceuticals Inc.

Presence of Foreign Substance

Official ID D-0655-2026 · Official record ↗

FDA Class III · Drug · July 8, 2026

Fexofenadine Hydrochloride Tablets recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

Official ID D-0654-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

IMULDOSA recall — ACCORD BIOPHARMA INC

Lack of assurance of Sterility:

Official ID D-0653-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep CLear recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0652-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep CLear recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0651-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Scrub Teal recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0650-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Scrub Teal recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0649-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0648-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0647-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

ChloraPrep FREPP recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0646-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Clear recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0645-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD PurPrep recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0644-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Official ID D-0643-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Perampanel CIII Tablets recall — SUN PHARMACEUTICAL INDUSTRIES INC

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

Official ID D-0628-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Povi-One recall — Elevate Oral Care

sub potency

Official ID D-0627-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Lacosamide Tablets recall — Annora Pharma Private Limited

Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.

Official ID D-0626-2026 · Official record ↗

FDA Class I · Drug · July 1, 2026

BD ChloraPrep FREPP Clear recall — CareFusion 213, LLC

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Official ID D-0625-2026 · Official record ↗

FDA Class I · Drug · July 1, 2026

BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (I recall — CareFusion 213, LLC

Non-Sterility: Due to presence of Aspergillus penicillioides.

Official ID D-0624-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

BD ChloraPrep FREPP Clear recall — CareFusion 213, LLC

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Official ID D-0623-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

BD ChloraPrep Clear recall — CareFusion 213, LLC

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Official ID D-0622-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

PReye Vitamin See Antioxidant Preservative Free Eye Drops recall — PReye LLC

Lack of Assurance of Sterility

Official ID D-0621-2026 · Official record ↗

FDA Class III · Drug · July 1, 2026

hydrOXYzine Hydrochloride Oral Solution recall — ANI Pharmaceuticals, Inc.

Presence of foreign substance

Official ID D-0619-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag recall — Central Admixture Pharmacy Services, Inc.

Incorrect product formulation: bag did not contain copper and famotidine per label.

Official ID D-0618-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

DULOXETINE D/R recall — Direct Rx

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Official ID D-0617-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Sensipar (cinacalcet) Tablets recall — Amgen, Inc.

CGMP Deviations

Official ID D-0616-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Corlanor (ivabradine) tablets recall — Amgen, Inc.

Presence of Foreign Substance.

Official ID D-0615-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Sensipar (cinacalcet) Tablets recall — Amgen, Inc.

CGMP Deviations

Official ID D-0614-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Sensipar (cinacalcet) Tablets recall — Amgen, Inc.

CGMP Deviations

Official ID D-0613-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Corlanor (ivabradine) tablets recall — Amgen, Inc.

Presence of Foreign Substance.

Official ID D-0612-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Fenofibrate Capsules recall — Ajanta Pharma USA Inc

CGMP Deviations

Official ID D-0611-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Carton Label recall — The Harvard Drug Group LLC

Subpotent Drug

Official ID D-0609-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0642-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0641-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0640-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0639-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0638-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0637-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0636-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0635-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Cura Hongos recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0634-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Rapidol recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0633-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Lil Drug Store recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0632-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Circle K recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0631-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Lucky Super Soft recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0630-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Lucky Super Soft recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Official ID D-0629-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Chlorthalidone Tablets recall — Inventia Healthcare Limited

Failed Dissolution Specifications

Official ID D-0610-2026 · Official record ↗

FDA Class III · Drug · June 24, 2026

Focalin XR (dexmethylphenidate HCl) 5 mg recall — Sandoz Inc

Labeling: Incorrect or Missing Lot and/or Exp Date

Official ID D-0608-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

safco SensiCaine-Ultra (20% Benzocaine) recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Official ID D-0606-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

PureLife recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Official ID D-0605-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Dental City TOPICAL ANESTHETIC GEL recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Official ID D-0604-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Burkhart topical anesthetic gel recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Official ID D-0603-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

DHP Topical Anesthetic Gel recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Official ID D-0602-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Quala Dental Products recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Official ID D-0601-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Official ID D-0600-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Buprenorphine HCl recall — Par Health USA, LLC

Crystallization; identified as Buprenorphine free base

Official ID D-0596-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Aripiprazole Tablets USP recall — Ajanta Pharma USA Inc

Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

Official ID D-0594-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Vasopressin 2 Units/2 mL in 0 recall — IntegraDose Compounding Services LLC

Subpotent Drug

Official ID D-0593-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

VistaPharm recall — PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

Official ID D-0592-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

VistaPharm recall — PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

Official ID D-0591-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

VistaPharm recall — PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

Official ID D-0590-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

VistaPharm recall — PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

Official ID D-0589-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Alyacen 7/7/7 recall — Glenmark Pharmaceuticals Inc., USA

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Official ID D-0588-2026 · Official record ↗

FDA Class I · Drug · June 17, 2026

BEEKEEPER'S NATURALS Saline Nasal Spray recall — BEEKEEPER'S NATURALS USA INC.

Microbial Contamination of Non-Sterile Products

Official ID D-0620-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Budesonide Inhalation Suspension recall — SUN PHARMACEUTICAL INDUSTRIES INC

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

Official ID D-0607-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Minocycline Hydrochloride Extended-Release Tablets recall — Ascend Laboratories, LLC

Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

Official ID D-0597-2026 · Official record ↗

FDA Class I · Drug · June 17, 2026

Gas-X Extra Strength recall — Haleon US Holdings LLC

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

Official ID D-0595-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

GSMS Incorporated recall — Golden State Medical Supply Inc.

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.

Official ID D-0587-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Zep recall — Zep Inc

Microbial contamination of sterile products

Official ID D-0586-2026 · Official record ↗

FDA Class III · Drug · June 17, 2026

Primidone Tablets recall — Amneal Pharmaceuticals, LLC

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Official ID D-0585-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Duloxetine Delayed-Release Capsules recall — Breckenridge Pharmaceutical, Inc.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Official ID D-0583-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Duloxetine Delayed-Release Capsules recall — Breckenridge Pharmaceutical, Inc.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Official ID D-0582-2026 · Official record ↗

FDA Class III · Drug · June 17, 2026

Epinephrine Injection recall — Fresenius Kabi USA, LLC

Failed Impurities/Degradations Specifications

Official ID D-0581-2026 · Official record ↗

FDA Class I · Drug · June 17, 2026

DOXOrubin Hydrochloride Liposome injection recall — SUN PHARMACEUTICAL INDUSTRIES INC

Presence of Particulate matter: Particulate matter identified as glass.

Official ID D-0580-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Xyvona (levorphanol tartrate tablets) recall — SUN PHARMACEUTICAL INDUSTRIES INC

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Official ID D-0599-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Xyvona (levorphanol tartrate tablets) recall — SUN PHARMACEUTICAL INDUSTRIES INC

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Official ID D-0598-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Niacin Extended-release Tablets recall — Lannett Company Inc.

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

Official ID D-0584-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

TopCare health recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0579-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

TopCare health recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0578-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

EQUALINE ultra strength recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0577-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

EQUALINE extra strength recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0576-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

GOODSENSE Ultra Strength recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0575-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

GOODSENSE Extra Strength recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0574-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

H recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0573-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

HyVee recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0572-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

HyVee recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0571-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Harris Teeter recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0570-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

FAMILY WELLNESS recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0569-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

FAMILY WELLNESS recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0568-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

DISCOUNT drug mart recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0567-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

CAREone recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0566-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

CAREone recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0565-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

MARKET BASKET ANTACID Calcium Carbonate 1000 mg recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0564-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

24/7 life BY 7-ELEVEN recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0563-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Extra strength Antacid Calcium Carbonate 750 mg recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0562-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Good Neighbor Pharmacy recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0561-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Good Neighbor Pharmacy recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0560-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

HALEON CALCIUM CARBONATE TUMS ANTACID recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0559-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

HALEON CALCIUM CARBONATE TUMS ANTACID recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0558-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

KIRKLAND Signature recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Official ID D-0557-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Amlodipine and Olmesartan Medoxomil Tablets recall — Ascend Laboratories, LLC

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Official ID D-0556-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Duloxetine DR Capsules recall — Asclemed USA Inc.

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

Official ID D-0555-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Lidocaine HCl Injection USP recall — Spectra Medical Devices, Llc

Lack of Assurance of Sterility

Official ID D-0554-2026 · Official record ↗

FDA Class III · Drug · June 10, 2026

Lidocaine HCl Injection recall — Eugia US LLC

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Official ID D-0552-2026 · Official record ↗

FDA Class III · Drug · June 3, 2026

PRED MILD recall — AbbVie Inc.

Failed Stability Specifications

Official ID D-0551-2026 · Official record ↗

FDA Class III · Drug · June 3, 2026

Nicotine Transdermal System Patch recall — AVEVA Drug Delivery Systems, Inc.

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

Official ID D-0550-2026 · Official record ↗

FDA Class I · Drug · May 27, 2026

MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%) recall — Wisconsin Pharmacal Company

Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.

Official ID D-0553-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Vitamin B-Complex recall — Safecor Health, LLC

Presence of a Foreign Substance; black particles observed in liquid

Official ID D-0549-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

fentaNYL Citrate recall — IntegraDose Compounding Services LLC

Subpotent Drug

Official ID D-0548-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

cimzia (certolizumab pegol) recall — UCB Biosciences Inc.

Lack of Assurance of Sterility

Official ID D-0546-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Erythromycin Tablets recall — Zydus Pharmaceuticals (USA) Inc

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

Official ID D-0545-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Erythromycin Tablets recall — Zydus Pharmaceuticals (USA) Inc

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

Official ID D-0544-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Estradiol Gel recall — ANI Pharmaceuticals, Inc.

Defective Container; packets were found to be either empty or partially full.

Official ID D-0543-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Gas-X recall — Haleon US Holdings LLC

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

Official ID D-0542-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Liraglutide Injection recall — Lupin Pharmaceuticals Inc.

Presence of particulate matter: a white thread-like structure in the cartridge

Official ID D-0541-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Busulfan Injection recall — Sagent Pharmaceuticals

Failed Impurities/Degradation Specifications

Official ID D-0539-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Atomoxetine Capsules HCL recall — Safecor Health, LLC

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

Official ID D-0538-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets recall — Amerisource Health Services LLC

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Official ID D-0537-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets recall — Amerisource Health Services LLC

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Official ID D-0536-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets recall — Golden State Medical Supply Inc.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Official ID D-0535-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets recall — Golden State Medical Supply Inc.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Official ID D-0534-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets USP recall — Lannett Company Inc.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Official ID D-0533-2026 · Official record ↗

FDA Class II · Drug · May 20, 2026

Ascend Laboratories recall — Ascend Laboratories, LLC

Failed Dissolution Specifications

Official ID D-0547-2026 · Official record ↗

FDA Class II · Drug · May 20, 2026

Buprenorphine Hydrochloride recall — ENDO USA, Inc.

Crystallization; identified as Buprenorphine free base

Official ID D-0527-2026 · Official record ↗

FDA Class II · Drug · May 20, 2026

Oasis Tears PF recall — Oasis Medical, Inc.

Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.

Official ID D-0525-2026 · Official record ↗

FDA Class I · Drug · May 13, 2026

Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INC

Presence of Particulate Matter.

Official ID D-0540-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

TPN bag (patient specific) recall — Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Incorrect Product Formulation: product did not contain insulin as listed in the label.

Official ID D-0524-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

NAPROXEN ORAL SUSPENSION recall — Acella Pharmaceuticals, LLC

Chemical contamination; presence of lead and lithium above specification

Official ID D-0523-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules USP recall — Breckenridge Pharmaceutical, Inc.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Official ID D-0522-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Enalapril Maleate Tablets recall — JB Chemicals and Pharmaceuticals Ltd

Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

Official ID D-0520-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Octreotide Acetate for Injectable Suspension recall — Teva Pharmaceuticals USA, Inc

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Official ID D-0519-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

BD PurPrep recall — CareFusion 213, LLC

Lack of assurance of Sterility: potential product contamination

Official ID D-0518-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

BD PurPrep recall — CareFusion 213, LLC

Lack of assurance of Sterility: potential product contamination

Official ID D-0517-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Official ID D-0516-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Official ID D-0515-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Official ID D-0514-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

DELFLEX recall — Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Official ID D-0513-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

DELFLEX recall — Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Official ID D-0512-2026 · Official record ↗

FDA Class III · Drug · May 13, 2026

busPIRone Hydrochloride Tablets recall — Unichem Pharmaceuticals USA Inc.

Subpotent drug

Official ID D-0511-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Alendronate Sodium Oral Solution recall — Hikma Pharmaceuticals USA INC

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

Official ID D-0526-2026 · Official record ↗

FDA Class III · Drug · May 6, 2026

Lidocaine Wound Gel (Benzalkonium Chloride recall — Water-Jel Technologies, LLC

Failed PH Specifications

Official ID D-0509-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution in 0 recall — Wells Pharma of Houston LLC

cGMP deviations.

Official ID D-0508-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Ketamine Hydrochloride Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Official ID D-0507-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution in 0 recall — Wells Pharma of Houston LLC

cGMP deviations.

Official ID D-0506-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Official ID D-0505-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate injectable Solution in 0 recall — Wells Pharma of Houston LLC

cGMP deviations.

Official ID D-0504-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Official ID D-0503-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Phenylephrine Hydrochloride Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Official ID D-0502-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Similasan recall — Thea Pharma, Inc.

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Official ID D-0501-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

iVIZIA recall — Thea Pharma, Inc.

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Official ID D-0500-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Optase Dry Eye Intense Drops (Glycerin 0 recall — SCOPE HEALTH

Lack of Assurance of Sterility

Official ID D-0499-2026 · Official record ↗

FDA Class III · Drug · May 6, 2026

Levocarnitine Injection recall — American Regent, Inc.

Labeling: Missing Label

Official ID D-0494-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

GenTeal Tears recall — Alcon Research LLC

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Official ID D-0492-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Systane recall — Alcon Research LLC

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Official ID D-0491-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Claravis (isotretinoin capsule recall — Teva Pharmaceuticals USA, Inc

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

Official ID D-0521-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

LACTATED RINGER'S IRRIGATION recall — B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Official ID D-0498-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

0 recall — B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Official ID D-0497-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

DEXTROSE INJECTION USP recall — B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Official ID D-0496-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Sterile Water for Injection USP recall — B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Official ID D-0495-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Omega-3-Acid recall — The Harvard Drug Group LLC

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

Official ID D-0493-2026 · Official record ↗

FDA Class III · Drug · April 29, 2026

Premier recall — Premier Dental Products Co

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to n…

Official ID D-0490-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

FRESHKOTE LUBRICANT EYEDROPS recall — Harrow Eye LLC

Lack of Assurance of Sterility

Official ID D-0489-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Furosemide Tablets recall — Leading Pharma, LLC

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

Official ID D-0486-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Pantoprazole Sodium recall — Hetero Labs Limited (Unit V)

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

Official ID D-0484-2026 · Official record ↗

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (vehicles aggregated here; car seats & tires not yet)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & egg products ↗ (not yet aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Sources last checked July 23, 2026 at 10:00 PM UTC.